Lifecare PCA 1428028Recalls & reported problems

ICU Medical, Inc. · Straight-Line Minibore PCA Set Integral PAV, Injector Assembly, Secure Lock, 80 Inch · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887787005537), received between Jan 15, 2019 and Jan 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Material Separation1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 15, 2019Material Separation; Material Separation
THE EVENT INVOLVED A CUSTOMER ALLEGATION OF A NDHEP PCA EXT SET 80IN THAT FAILED AT THE SLIDE CLAMP RETAINER ON AN UNKNOWN DATE. A LOSS OF FLUID AS WELL AS BLOOD WAS VISUALIZED BY THE NURSE ON THE FLOOR, DESCRIBED AS MINIMAL. THERE WAS PATIENT INVOLVEMENT WITH ADVERSE EVENT, WITH UNKNOWN DELAY IN CRITICAL THERAPY AND UNKNOWN NEED FOR ANY MEDICAL INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8251108 ↗

Device details

UDI-DI	`10887787005537`
Brand	Lifecare PCA
Model	1428028
Company	ICU Medical, Inc.
Product code	MEA · Pump, infusion, pca
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 17, 2025

Device type (GMDN): Electric infusion pump administration set, single-use

A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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